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Pink Sheet - Accelerated Approval For Medicare Coverage? FDA Model Could Be Useful For Value-Based Agreements

Executive Summary

Centers for Medicare & Medicaid Innovation could enable outcomes-based contracting for novel, 'curative' therapies follow something like the FDA’s Accelerated Approval model, former top HHS official suggests.


One option for the US Medicare program to enable outcomes-based pricing agreements would be to create a demonstration project that applies something similar to the US Food & Drug Administration’s Accelerate Approval model to coverage and payment.


Pink Sheet - US FDA 'Uni-Review' Rolls Out: Psychiatric Division Is Among Early Adopters

Executive Summary

Shared review memorandum under Office of New Drugs reorg will help eliminate last-minute surprises between disciplines and provide greater consistency between divisions.


The US Food and Drug Administration’s Division of Psychiatry Products has one of the first review teams currently testing out the agency’s proposed new integrated review document as part of the “modernization” of the Office of New Drugs.

Pink Sheet - FDA's Pazdur Advocates Platform Trials For Cancer Drug Development

Executive Summary

US FDA is encouraging common mechanisms of drug testing to enable pharma industry collaboration and avoid redundancy; Pazdur notes that there are many similar PD-1 drugs.


Richard Pazdur, the director of US Food and Drug Administration's Oncology Center of Excellence, has one plea for industry: work together to develop new cancer drugs. He said the agency is trying to foster this collaboration by encouraging the use of platform trials and common controls.


The Cancer Letter - Real-world data, evidence should be leveraged in clinical research to better include and ultimately treat larger patient populations

The growth of personalized medicine in oncology continues to fuel a shift from traditional chemotherapies to immunotherapy. Currently, there are more than 30 immunotherapies approved for use in the United States, with more than 2,300 immunotherapy clinical trials listed on


Forbes - AI (Artificial Intelligence): What’s The Next Frontier For Healthcare?

Perhaps one of the biggest opportunities for AI (Artificial Intelligence) is the healthcare industry. According to ReportLinker, spending on this category is forecasted to jump from $2.1 billion to $36.1 billion by 2025. This is a hefty 50.2% compound annual growth rate (CAGR).


So then what are some of the trends that look most interesting within healthcare AI? Well, to answer this question, I reached out to a variety of experts in the space.


Here’s a look:


Ori Geva, who is the CEO of Medial EarlySign:

White House Sees Drug Price Opening to Work with Democrats

The White House sees an opening for a drug pricing deal with House Democrats before the end of President Donald Trump’s first term—provided impeachment doesn’t derail the entire process.


The White House Domestic Policy Council is working through technical aspects of a Medicare negotiation bill backed by House Speaker Nancy Pelosi (H.R. 3), Joe Grogan, director of the council and former Gilead Sciences lobbyist, said at Friends of Cancer Research and Prevision Policy’s Oct. 7 biopharma conference.


Endpoints News - Ned Sharpless in final running for FDA commish with MD Anderson exec and Harvard prof — reports

The Trump administration is apparently down to three final candidates for the top FDA job as a deadline for nomination looms. Acting commissioner Ned Sharpless is contending with Stephen Hahn, chief of radiation oncology at MD Anderson, and Harvard dermatology professor Alexa Boer Kimball, according to reports.

Pink Sheet - US FDA Commissioner Transition: Sharpless Audition Is Ending – Will He Get The Part?

It has been six months since Scott Gottlieb announced that he would be resigning as commissioner of the US Food & Drug Administration, and there is still no formal nominee to succeed him.


That is likely to change soon: under federal law governing vacancies for Senate confirmed positions, an agency can only be led by an “acting” for a maximum of 210 days before a nomination is made (or someone else is put in the acting role). That deadline is approaching at the start of November, and all indications are that the White House will make a formal nomination before then.

Endpoints News - Ex-FDA chiefs, non-profits take Ned Sharpless' corner as clock ticks down on Trump's pick

Just a few days after a report surfaced noting that HHS Secretary Alex Azar was pushing for controversial secretary for health Brett Giroir to take the helm at the FDA from acting chief Norman “Ned” Sharpless, a new report has surfaced noting some high-profile support gathering in Sharpless’ corner.

This time the messenger was The Washington Post, which may not sit well with a president who has repeatedly lashed the newspaper for what he feels is an anti-Trumpian stance.


The Washington Post - Former agency heads, health groups push for FDA’s Sharpless to be permanent commissioner

The jockeying over who will be the next Food and Drug Administration commissioner intensified Tuesday when former agency heads and dozens of health groups urged the White House to nominate acting FDA chief Norman “Ned” Sharpless to become the agency’s permanent commissioner.